Regulatory Project Associate - Clinical Trials
- Experience Level
- Entry level
At AstraZeneca we are guided in our work by a strong set of values, and we're resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we're on a mission to turn ideas into life-changing medicines that transform lives. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you're swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
The Regulatory Project Associate (RPA) supports planning, preparation and delivery of Clinical Trial Application (CTA) related regulatory documents to Health Authorities and/or Marketing Companies. The CTA RPA position sits within the Regulatory Project Management team within Late Respiratory, Inflammation and Autoimmunity (RIA) Regulatory Affairs, which is part of BioPharmaceuticals R&D. The Regulatory Project Management team is accountable for end to end delivery of regulatory submissions in line with business priorities by providing regulatory expertise, efficient project management, and strong leadership within the RIA area.
We are now recruiting for a permanent CTA RPA position. We expect you to have experience from working in Regulatory Affairs, or elsewhere in the Pharmaceutical industry.
Responsibilities will include, but will not be limited to:
- Planning, preparing, handling, distributing and submitting regulatory documents to Health Authorities and/or Marketing Companies, globally, in support of clinical trials.
- Performing regulatory review of clinical trial related documents
- Document management including updating and tracking study specific regulatory files and systems according to established AZ procedures and regulatory requirements
- Ensuring that all work is performed in accordance with established procedures and regulatory requirements
- Contributing to improvement of internal processes
- University Degree in Science or related discipline
- Relevant regulatory experience or experience elsewhere in Pharmaceutical Industry e.g. CRO, Marketing Company, Health Authority
- Excellent written and verbal communication skills
- Proficient verbal and written English
- Demonstrated good organization and time management skills and ability to manage tight timelines when required
- Ability to work in teams and collaborate closely with other functions
- Proficiency in various computer applications and the ability to quickly gain knowledge of, and operate in, internal databases
- Enthusiasms when working with administrative tasks with keen attention to detail